2 g / 0.25 g and 4 g / 0.5 g powder for solution for infusion piperacillin
/ tazobactam
What Piperacillin / Tazobactam Sandoz is and what it is used for
Piperacillin belongs to a group of medicines called ‘broad-spectrum penicillin antibiotics’. It can kill many types of bacteria. Tazobactam may prevent certain resistant bacteria from surviving the effects of piperacillin. This means that more types of bacteria are killed when piperacillin and tazobactam are given together.
Piperacillin / Tazobactam Sandoz is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin, or blood. Piperacillin / Tazobactam Sandoz can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
Piperacillin / Tazobactam Sandoz is used in children aged 2-12 years to treat infections in the abdomen, such as appendicitis, peritonitis ( infection of the fluid and the lining of the abdominal organs), an infection of the gallbladder. Piperacillin / Tazobactam Sandoz can be used to treat bacterial infections in patients with low white blood cell count (reduced resistance to infections ).
In case of some serious infection, your doctor may consider using Piperacillin / Tazobactam Sandoz in combination with other antibiotics.
Piperacillin and tazobactam contained in Piperacillin / Tazobactam Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Piperacillin / Tazobactam Sandoz
Do not use Piperacillin / Tazobactam Sandoz
- if you are allergic to piperacillin or tazobactam or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to antibiotics called penicillins, cephalosporins, or other beta-lactamase inhibitors, you may be allergic to Piperacillin / Tazobactam Sandoz.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Piperacillin / Tazobactam Sandoz:
- if you have allergies is. If you have multiple allergies, be sure to tell your doctor or another healthcare provider before receiving this product.
- if you have diarrhea before, or if you get diarrhea during or after treatment. In this case, be sure to tell your doctor or another healthcare professional immediately. Do not take any medicine for diarrhea without first checking with your doctor.
- if you have low potassium levels in your blood. Your doctor may want to check your kidneys before you receive this medicine and he/she may perform regular blood tests during treatment.
- if you have any kidney or liver problems or receive hemodialysis. Your doctor may want to check your kidneys before you receive this medicine and he/she may perform regular blood tests during treatment.
- if you are taking certain medicines (called anticoagulants) to avoid excessive blood clotting (see also “Other medicines and Piperacillin / Tazobactam Sandoz” in this information) or if any unexpected bleeding occurs during treatment. In this case, tell your doctor or another healthcare professional immediately.
- if you get cramps during treatment. In this case, tell your doctor or other healthcare professional about it.
- if you think you have a new or worsening infection. In this case, tell your doctor or other healthcare professional about it.
Children under 2 years
The use of piperacillin/tazobactam is not recommended for use in children below 2 years of age due to insufficient data on safety and efficacy.
Other medicines and Piperacillin / Tazobactam Sandoz
Tell your doctor or another healthcare professional if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Some medicines may affect or be affected by piperacillin and tazobactam. This applies:
- medicines for gout (probenecid). This can increase the time it takes for piperacillin and tazobactam to leave the body.
- drugs that thin the blood or treat blood clots (eg heparin, warfarin, or acetylsalicylic acid ).
- medicines used to relax your muscles during surgery. Tell your doctor if you are going to be anesthetized
- with methotrexate (a medicine used to treat cancer, arthritis, or psoriasis ). Piperacillin and tazobactam may increase the time it takes for methotrexate to leave the body.
- medicines that lower the level of potassium in the blood (eg tablets that increase urination or certain medicines for cancer).
- medicines containing the other antibiotics tobramycin, gentamycin, or vancomycin. Tell your doctor if you have kidney problems.
Effects on laboratory tests
Tell your doctor or laboratory staff that you are taking Piperacillin / Tazobactam Sandoz if you have to take a blood or urine sample.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine.
Your doctor will decide if Piperacillin / Tazobactam Sandoz is right for you.
Piperacillin and tazobactam can pass to the baby in the womb or pass to breast milk. If you are breastfeeding, your doctor will decide if Piperacillin / Tazobactam Sandoz is right for you.
Driving and using machines
The use of Piperacillin / Tazobactam Sandoz is not expected to affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Piperacillin / Tazobactam Sandoz contains excipients
Piperacillin / Tazobactam Sandoz 2 g / 0.25 g contains 109 mg sodium (the main ingredient in table salt / table salt) per unit dose. This corresponds to 6% of the maximum recommended daily intake of sodium for adults.
Piperacillin / Tazobactam Sandoz 4 g / 0.5 g contains 217 mg sodium (the main ingredient in table salt / table salt) per unit dose. This corresponds to 11% of the maximum recommended daily sodium intake for adults.
This should be taken into account if you have been prescribed a low-salt diet.
How to use Piperacillin / Tazobactam Sandoz
Your doctor or other healthcare professional will give you this medicine by infusion (a 30-minute drip) into one of your veins.
Dosage
The dose of medicine you are given depends on what you are being treated for, your age, and whether you have kidney problems or not.
Adults and adolescents over 12 years
The usual dose is 4 g / 0.5 g piperacillin/tazobactam given every 6-8 hours as an infusion into one of your veins (directly into the bloodstream).
Patients with kidney problems
Your doctor may need to reduce the dose of Piperacillin / Tazobactam Sandoz or how often you get it. Your doctor may also want to test your blood to ensure that the treatment is given at the right dose, especially if you have to take the medicine for a long time.
Children aged 2 to 12 years
The usual dose for children with abdominal infections is 100 mg / 12.5 mg piperacillin/tazobactam per kg body weight given every 8 hours in a vein (directly in the bloodstream). The usual dose for children with low white blood cell count is 80 mg / 10 mg piperacillin/tazobactam per kg body weight given every 6 hours in a vein (directly in the bloodstream).
Your doctor will calculate a dose depending on your child’s body weight, but each dose should not exceed 4 g / 0.5 g Piperacillin / Tazobactam Sandoz.
You will be given Piperacillin / Tazobactam Sandoz until the signs of infection have completely disappeared (5 to 14 days).
If you take more Piperacillin / Tazobactam Sandoz than you should
Because you are being given Piperacillin / Tazobactam Sandoz by a doctor or other healthcare professional, it is unlikely that you will be given the wrong dose. However, if you experience side effects such as cramps or if you think you have had too much, tell your doctor immediately.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you miss a dose of Piperacillin / Tazobactam Sandoz
If you think you have not received a dose of Piperacillin / Tazobactam Sandoz tell your doctor or another healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of these potentially serious side effects for Piperacillin / Tazobactam Sandoz:
The serious side effects ( frequency in brackets) of Piperacillin / Tazobactam Sandoz are:
- severe skin rash ( Stevens-Johnson syndrome, bullous dermatitis (reported), exfoliative dermatitis (reported), toxic epidermal necrolysis (rare)), which initially appear as reddish target-like dots or round spots, often with blisters in the middle, on the bonfire. Additional signs are sores in the mouth, throat, nose, arms, legs, and genitals as well as eye inflammation (red and swollen eyes). The skin rash can worsen to widespread blistering or flaking of the skin and can be life-threatening.
- severe allergic condition with potentially fatal outcome (drug reaction with eosinophilia and systemic symptoms) that can affect the skin but especially internal organs, such as kidneys and liver (has been reported)
- a skin condition ( acute generalized exanthematous pustulosis ) followed by fever consisting of a large number of very small fluid-filled blisters on large parts of the skin, which become swollen and red (have been reported)
- swelling of the face, lips, tongue, or other parts of the body (has been reported)
- shortness of breath, wheezing, or difficulty breathing (has been reported)
- severe skin rash or hives (uncommon), itching or rash (common)
- whites of the eyes or skin yellow (has been reported)
- damage to blood cells (signs of this may be shortness of breath for no reason, urine turning red or brown (has been reported), nosebleeds (rare), or bruises in the form of small dots (purpura) (has been reported)), greatly reduced number of whites blood cells (rare)
- severe or persistent diarrhea followed by fever or weakness (rare)
Very common side effects ( may affect more than 1 user in 10):
- diarrhea
Common side effects ( may affect up to 1 in 10 people):
- fungal infection
- decreased platelet count, decreased red blood cell count or blood pigment/hemoglobin, abnormal laboratory test results (positive direct Coombs), prolonged coagulation time (prolonged activated partial thromboplastin time)
- decreased protein content in the blood
- headache, insomnia
- stomach pain, vomiting, nausea, constipation, upset stomach
- increased levels of liver enzymes in the blood
- abnormal blood tests for kidney function
- fever, injection site reaction
Uncommon side effects ( may affect up to 1 in 100 people):
- decrease in white blood cell count ( leukopenia ), prolonged coagulation time (prolonged prothrombin time)
- decrease in potassium levels in the blood ( hypokalaemia ), decreased blood sugar (blood glucose)
- low blood pressure, inflammation of the veins (feels like tenderness or redness in the affected area)
- reddening of the skin
- increased content of a degradation product from blood pigments ( bilirubin )
- skin reactions with redness, skin changes, hives
- joint and muscle pain
- frostbite
Rare side effects ( may affect up to 1 in 1,000 people):
- inflammation of the mucous membranes of the mouth
Has been reported (occurs in an unknown number of users):
- sharply reduced number of red blood cells, white blood cells, and platelets (pancytopenia), decreased number of white blood cells ( neutropenia ), decreased number of red blood cells due to premature degradation, prolonged bleeding time, increased number of platelets, increased number of certain types of white blood cells ( eosinophilia) )
- allergic reaction and severe allergic reaction
- hepatitis, renal impairment, and kidney problems
- a type of lung disease with an increased number of eosinophils (a type of white blood cell ) in the lungs
Treatment with piperacillin has been associated with an increased incidence of fever and rash in patients with cystic fibrosis.
How to store Piperacillin / Tazobactam Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. or EXP. The expiration date is the last day of the specified month.
Unopened vials/glass vials
No special storage instructions.
For storage instructions for reconstituted/diluted solution, see the end of the package leaflet under “The following information is intended for medical or healthcare professionals only”.
For single use only. Discard any unused solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substances are piperacillin and tazobactam.One vial contains 2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as tazobactam sodium).One vial or glass vial contains 4 g piperacillin (as piperacillin sodium) and 0.5 g tazobactam (as tazobactam sodium).
- Other ingredients: This medicine does not contain any other ingredients other than the active substances.
What the medicine looks like and the contents of the pack
Piperacillin / Tazobactam Sandoz 2 g / 0.25 g is a white to off-white powder for solution for infusion, packaged in a vial a glass vials are packaged in cartons
Pack sizes: 1, 5, 10, 12 and 50 vials.
Piperacillin / Tazobactam Sandoz 4 g / 0.5 g is a white to off-white powder for solution for infusion, packaged in vials or vials. The vials or glass bottles are packed in cartons.
Pack sizes: 1, 5, 10, 12 and 50 vials / vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria